Cleared Traditional

K203586 - EndoSerter-PL (FDA 510(k) Clearance)

Class I Ophthalmic device.

K203586 · Corneagen, Inc. · Ophthalmic device
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Feb 2022
Decision
421d
Days
Class 1
Risk

K203586 is an FDA 510(k) clearance for the EndoSerter-PL. Classified as Graft Insertion Instrument For Endothelial Keratoplasty (product code OTZ), Class I - General Controls.

Submitted by Corneagen, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on February 2, 2022 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Corneagen, Inc. devices

Submission Details

510(k) Number K203586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2020
Decision Date February 02, 2022
Days to Decision 421 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
311d slower than avg
Panel avg: 110d · This submission: 421d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OTZ Graft Insertion Instrument For Endothelial Keratoplasty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
Definition A Graft Insertion Device For Endothelial Keratoplasty Is A Device Intended To Be Inserted Into The Eye During Surgery To Direct The Insertion Of A Corneal Graft And Be Removed After Insertion Is Completed.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

K.Hodai Consulting, Inc.
Omid Kodai

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.